A pharmaceutical company is recalling birth control pills that were distributed to wholesalers, clinics and retail pharmacies across the country over a packaging error.
The birth control tablets are sold under the name Mibelas 24 Fe.
According to the Food and Drug Administration, the first four days of the blister packet have four nonhormonal placebo tablets as opposed to the active tablets.
“Oral contraceptive tablets that are taken out of sequence may place the user at risk for contraceptive failure and unintended pregnancy,” the announcement on the FDA website states.
Lupin Pharmaceuticals said a packaging error caused the blister packet to be rotated 180 degrees within the wallet, reversing the weekly tablet orientation.
The recalled product will have the lot number L600518 and an expiration date of May 2018. (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg.)
However, because of the packaging error, the lot number and expiration date on the recalled product are no longer visible.
“These products are packaged in blister packs containing 28 tablets: 24 white to off-white tablets of active ingredients debossed with ‘LU’ on one side and ‘N81’ on the other; and 4 tablets of inert ingredients debossed with ‘LU’ on one side and ‘M22’ on the other side,” the FDA stated.
“For patients in whom a pregnancy is contraindicated or in whom concomitant medication(s) may have teratogenic effects, an unintended pregnancy may cause significant adverse maternal or fetal health consequences, including death.”
There had been no reports of adverse events linked to the recall as of May 25.
Lupin is notifying its distributors and customers by recall letter and is arranging for return of all recalled products, according to the FDA.
“Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product,” the FDA stated.
Consumers with questions regarding this recall can contact Lupin at 1-800-399-2561 from 6 a.m. to 3 p.m. MDT, Monday through Friday.